Device for examining and surgically operating on body cavities, in particular the anal and vaginal cavities

ABSTRACT

A device for examining and surgically operating on a body cavity, in particular an anal or vaginal cavity, includes an elongate hollow body exhibiting an insertion portion for at least a partial insertion of the device internally of the cavity and an open portion, arranged on an opposite side to the insertion portion, through which the cavity is at least partially visible or reachable by at least a surgical instrument. At least a part of the hollow body exhibits a structural sector which is interposed between the insertion portion and the open portion in order to be positioned in the cavity. The structural sector has a longitudinal window through which a portion of the cavity affected by a pathology can be isolated. In a transversal section, the structural sector extends in a substantially curved development and exhibits opposite ends which are substantially parallel to one another, so as to divaricate the cavity while keeping tensioned the portion of the cavity affected by the pathology and prevent sagging thereof inside the hollow body.

TECHNICAL FIELD

The invention relates to a device for examining and surgically operatingon body cavities, in particular the anal and vaginal cavities.

The invention relates to the medical/surgical field, and in particularconcerns inspections and/or surgical operations on body cavities, suchas the anal and vaginal cavities.

In particular, the invention is usefully applied in inspecting and/orsurgically treating coloproctological pathologies, such as for examplehaemorrhoids, anal fissures, recto-vaginal fistulas, papillomas,rectoceles, anal cancers, fibrous polyps, hypertrophic anal papillomas,rectal prolapse, ulcerous rectocolitis, Crohn's disease, polyposis,colorectal tumours and the like.

BACKGROUND ART

As is known, inspection and/or surgical treatment of anal and/or vaginalorifices which are suffering from a pathological condition normallyrequires the use of devices which open the cavity, allowing visualinspection to be performed as well as offering accessibility to one ormore surgical instruments.

These devices normally exhibit a hollow elongate body predisposed to beinserted into the cavity.

Generally the hollow body exhibits an open end for insertion of thesurgical instruments needed for the operation. At the open end, thehollow body is provided with a handle gripped by the doctor duringdiagnostic examinations, or by the surgeon undertaking the operation.

In certain cases the handle also functions as a housing body for a lightsource for illuminating the inside of the anal and/or vaginal canal.

With particular reference to some coloproctological pathologies, themain surgical intervention techniques which include use of divaricators,such as the ones mentioned above, are based on the removal of tissue,i.e. the surgical removal of the portions of rectal mucosa which areaffected by the pathology.

In these techniques the removal of haemorrhoidal prolapse is possibletogether with the suturing of the cut zones, as described andillustrated in WO 01/21060.

In this case, the divaricator accessory used for the surgicalintervention exhibits a hollow body developing longitudinally in an opensemi-cylindrical conformation.

In the above prior art, the hollow body exhibits two open opposite ends.

A first end is predisposed to be inserted internally of the respectivecavity, and a second end is predisposed to remain external of the cavityin order to enable the surgeon to introduce all the instrumentsnecessary for the operation.

The hollow body is insertable in the cavity by means of an anatomicalcone-shaped introducer. In this way the hollow body is made to slidelongitudinally with respect to the anatomical cone-shaped introducerinternally of the patient's body.

At the open introductory end, the hollow body also exhibits an openingor window for intercepting a part of the haemorrhoidal prolapse and forenabling extrusion thereof for subsequent removal and suture thereof bymeans of the appropriate surgical instruments.

In order to enable a sufficient space in which to work, the accessorydivaricator device exhibits, in transversal section, a semi-circulardevelopment which enables partial divarication of the cavity at the partinterested by the pathology.

Also known in the prior art, and as described in document EP1183991, aredivaricator devices the hollow body of which, presenting an elongateconformation, exhibit an insertion end which is closed and an oppositeend which is open and through which it is possible to reach theinterested portion of body cavity. In this case, in transversal sectionthe hollow body exhibits a substantially circular profile, interruptedaccording to an arc of circumference the length of the span of which isshorter than the diameter of the profile itself. In other words, thetransversal section of the hollow body exhibits a substantially C-shapedprofile the terminal portions of which converge to constitute respectivesupport and/or rest arches for angular portions of the wall of the bodycavity under examination.

The present applicant has noted that known-type divaricator devices arenot free of some drawbacks, principally in relation to the effectivenessthereof in terms of divarication of the cavity during the stage ofdiagnostic examination and/or surgical operation in patients exhibitingnotable muscle hypotone or in patients affected, for example byrectoceles or by similar pathologies.

In particular, it has been seen that in cases of patients with musclehypotone in the sphincter or in perineal zones not having musculartissue, for example the female perineal zone interpositioned between theanal cavity and the vaginal cavity, the tissue interested by a pathologytends to sag, invading the space delimited by the hollow body of thedivaricator. From the diagnostic point of view this leads to greaterdifficulty in completely viewing and examining the pathology, and fromthe surgical point of view means the operation site is not sufficientlyfree for necessary manoeuvres.

This disadvantage is encountered both during use of a divaricator likethe one illustrated in FIG. 1, which in transversal section exhibits asemicircular profile, and during the use of a divaricator as illustratedin FIG. 2, which is substantially C-shaped. In the first case (FIG. 1)the sagging and/or the pathological tissue significantly invades thespace delimited by the hollow body. In the second case (FIG. 2) thesagging tissue and/or the pathological tissue is slightly supported byterminal portions of the transversal section of the hollow body, butnonetheless falls internally thereof across the interrupted part of thesection thereof.

Also noteworthy is the fact that none of the above-described devicesenables the surgeon to localise and circumscribe the operation zone fortreatment of the pathology.

From the anatomical point of view, the initial longitudinal section ofthe human anal canal includes a first portion, about 2.5-3 cm deep,called the anatomical anal canal, and a second portion, about 5-5 cmdeep, known as the surgical anal canal.

The two portions are subdivided by a line of folds known as Morgagni'srectal columns.

The fold line delimits the pain threshold as below it a surgicalintervention is better avoided as it causes very great pain to thepatient upon waking from the anaesthetic, while above the lineoperations can be performed without causing the patient discomfort; itis for this reason that this second portion is called the surgical analcanal.

The prior-art devices exhibit a longitudinal window over the wholelength of the hollow body, and therefore do not isolate the part to betreated.

Indeed, the anal tissue that falls into the hollow body belongs both tothe first portion, which does not necessarily have to be surgicallytreated, and for the second portion.

In certain cases the first portion can even obscure the second portioni.e. the part to be surgically treated.

The applicant has therefore found that in order to safeguard the patientit is advisable to protect this area, in order to prevent the surgicalinstruments, for example needles, from accidentally causing lesions inthe tissue of the first portion, as well as to prevent the tissue fromthose zones' limiting the operativity of the surgeon by invading theoperational area.

The present invention is therefore aimed at providing a device forexamination or surgical operation on body cavities, in particular analand/or vaginal cavities, which obviates the above-cited drawbacks in theprior art.

A fundamental aim of the invention is to provide a device for examiningand/or surgically operating on the anal and/or vaginal cavities whichdevice leaves the visual field afforded by the device and the operatingspace for the hollow body of the device free.

A further aim of the present invention is to provide a device forexamination of and/or surgical operation on the cavities which cancircumscribe the intervention zone for treatment of the pathology.

A further aim of the present invention is to prevent hypotonic softtissues and/or anal pathologies of the anal or vaginal cavities frominvading the internal space of the hollow body of the device.

The set aims and more besides are all attained by a device forinspection or surgical intervention of body cavities, in particular analand/or vaginal cavities, as specified in the appended claims.

DISCLOSURE OF INVENTION

There now follows, by way of non-exclusive example, a description of apreferred embodiment of a device for examination or surgicalintervention on body cavities, in particular anal and/or vaginalcavities, in accordance with the accompanying figures of the drawings,in which:

FIG. 1 is a transversal section of a device for examination or surgicalintervention on the anal cavity according to a first solution in theprior art;

FIG. 2 is a transversal section of a device for examination or surgicalintervention on the anal cavity according to a second solution in theprior art;

FIG. 3 is a perspective view of a device for examination or surgicalintervention on body cavities, in particular the anal and/or vaginalcavities, in accordance with a first embodiment of the presentinvention;

FIG. 4 is a transversal section of the device of claim 3;

FIG. 5 is a perspective view of a device for examination or surgicalintervention on body cavities, in accordance with a second embodiment ofthe present invention;

FIG. 6 is a transversal section of a device for examination or surgicalintervention on body cavities, in accordance with a third embodiment ofthe present invention;

FIG. 7 is a transversal section of a device for examination or surgicalintervention on body cavities, in accordance with a fourth embodiment ofthe present invention;

FIG. 8 is a transversal section of a device for examination or surgicalintervention on body cavities, in accordance with a fifth embodiment ofthe present invention;

FIG. 9 is a transversal section of a device for examination or surgicalintervention on body cavities, in accordance with a sixth embodiment ofthe present invention.

With reference to FIGS. 3 to 8, 1 denotes in its entirety a device forexamination or surgical intervention on body cavities, in particularanal and/or vaginal cavities, in accordance with the present invention.

As is evident in FIGS. 3 to 5, the device comprises a hollow body 2having a substantially elongate shape and exhibiting an insertionportion 3 for at least partial insertion of the device 1 internally of acavity A which can be either anal or vaginal, and an open portion 4,arranged on an opposite side with respect to the insertion portion 3,through which the cavity A is at least partially visible or reachable byat least a surgical instrument.

In order to enable easy insertion of the device 1 in the cavity A to beexamined and/or to be surgically operated upon, while at the same timepreventing an exit of organic material, for example faeces or the like,the insertion portion 3 is substantially closed and rounded, andpreferably tapered.

With reference to FIGS. 3 and 5, the hollow body 2 narrows towards theinsertion portion 3 and broadens towards the open end 4 at which openend 4 the hollow body 2 exhibits a truncoconical portion 4 a predisposedto rest on the body of a patient at the peripheral zone of the cavity Ato be examined and/or surgically treated.

As can be seen in FIGS. 3 and 5, the hollow body 2 exhibits alongitudinal window 5 for inspection and/or intervention through whichthe pathological situation to be treated can be isolated. Thelongitudinal window 5 develops between the open portion 4 and theinsertion portion 3, preferably without being part of either one.

In more detail, as can be seen in FIGS. 3 and 5, the longitudinal window5 starts downstream of the insertion portion 3 and terminates upstreamof the open portion 4, being thus closed and entirely contained betweenthe two portions 3, 4.

With reference to FIG. 4 and from 6 to 8, at least a longitudinalportion of the hollow body 2, corresponding to the longitudinal window5, exhibits, in transversal section, a structural sector 6 which extendsin a curve, and is preferably semicircular.

The structural sector 6 advantageously exhibits opposite ends 7 whichextend in non-converging directions so as to divaricate the cavity whileat the same time maintaining the portion of cavity A affected by thepathology at a tension which is sufficient for it to be viewed and/ortreated.

In particular, the distance D between the ends 7 of the structuralsector 6 of the hollow body 2 is greater than or equal to a referencespan C of the curved development of the structural sector 6, which spanC is longer than any other span which can be traced across the samecurved profile.

In the present embodiment of substantially semi-circular structuralsectors 6, the maximum span C corresponds to the diameter of thesemicircular profiles, for which reason the distance D between the twoends 7 of the respective structural sectors 6 is greater than or equalto the respective maximum spans C.

With reference to the embodiment illustrated in FIG. 6, the ends 7 ofthe structural sector 6 of the hollow body develop in divergentdirections.

With reference to the embodiments illustrated in FIG. 4 and from 7 to 9,the ends 7 of the structural sector 6 of the hollow body 2 develop insubstantially diverging directions.

With reference to the embodiment represented in FIGS. 4 and 7, the endsof the structural sector 6 of the hollow body 2 develop in divergingstraight directions.

With reference to the embodiments represented in FIGS. 8 and 9, each end7 of the structural sector 6 of the hollow body 2 has a curvedtransversal section.

In the embodiment illustrated in FIG. 8, the curved ends 7 of thestructural sector 6 exhibit concavities 7 a which face in oppositedirections, each towards an outside of the hollow body 2.

In the embodiment of FIG. 9, the curved ends 7 of the structural sector6 exhibit concavities 7 a which at least partially face one another. Inother words, the concavities 7 a of the curved ends 7 face a medianplane interpositioned between the ends 7.

Still with reference to FIG. 9, the curved ends 7 of the structuralsector 6 are at least partially opposite-facing with respect to thestructural sector 6 in such a way as at least partially to face thepathological site to be examined and/or surgically treated.

With reference to the appended FIGS. 3 and 5, the ends 7 each exhibit aninitial tract, which intersects the open portion 4, connected to eachother via a preferably convex bridge 10.

The bridge inferiorly delimits the closed longitudinal window 5.

The hollow body 2 internally exhibits at least a channel 8 forfacilitating and permitting a manoeuvring of a diagnostic and/orsurgical instrument which is necessary for the type of interventionbeing performed.

The channel 8 is advantageously afforded at least partially along thelongitudinal development of the hollow body 2.

With reference to the embodiment of FIG. 5, the device 1 is furtherprovided with a handle 9 which can be gripped manually in order toorient and displace the device simply and precisely during theexamination and/or surgical operation. The handle 9 is solidlyconstrained to the hollow body 2 at the open portion 4 thereof and is atan opposite side thereof to the longitudinal window 5.

The invention solves the problems encountered in the prior art andoffers important advantages.

Firstly, the above-described device is well designed for diagnosticexaminations and/or surgical operations in relation to variouspathologies which interest the anal and/or vaginal cavities.

Also, the device can permit viewing, isolating and/or reaching the areaaffected by the pathology following an obvious procedure and avoidingobstacles, even in situations where there is muscle hypotone and/orpathologies which soften the surrounding tissues of the cavities,causing them to droop or sag.

Advantageously the arranging of a hollow body which in transversalsection exhibits substantially parallel or diverging development enablesthe interested portions of cavity to be tensed, which keeps the affectedarea in the zone of the longitudinal window of the hollow body.

Further, the presence of the bridge 10 at the open zone 4 prevents thepart of the anal cavity which is not involved with the surgicaloperation from falling into the inside of the hollow body 2.

In this way the space for manoeuvring and viewing is free and delimited,facilitating the work of the doctor or surgeon in the diagnostic and/orsurgical treatment operations.

The invention claimed is:
 1. A device for examining and surgicallyoperating on an anal or vaginal cavity, comprising an elongate hollowbody exhibiting an insertion portion for at least a partial insertion ofthe device internally of the cavity and an open portion, arranged on anopposite side to the insertion portion, through which the cavity is atleast partially visible or reachable by at least a surgical instrument,the hollow body narrowing towards the insertion portion and broadeningtowards the open portion, at least a part of the hollow body comprisinga structural sector which is positionable in the cavity, the structuralsector having a longitudinal window through which a portion of thecavity affected by a pathology can be isolated, wherein, in atransversal section, the structural sector extends in a substantiallycurved development and exhibits opposite end portions which aresubstantially parallel to one another and extend in a straightdevelopment, so as to divaricate the cavity while keeping tensioned theportion of the cavity affected by the pathology and prevent saggingthereof inside the hollow body, a convex bridge inferiorly delimitingthe longitudinal window at the open portion, the device furthercomprising a handle which can be manually gripped in order to orient anddisplace the device during examination or surgical operations, thehandle being solidly constrained to the hollow body at the open portionthereof.
 2. The device according to claim 1, wherein a distance betweenthe opposite end portions of the structural sector of the hollow body isgreater than, or equal to, a reference span of the curved development ofthe structural sector, said reference span being longer than other spanswhich can be identified in the curved development of the structuralsector.
 3. The device according to claim 1, wherein the hollow bodyinternally exhibits at least a channel for manoeuvring at least adiagnostic and/or a surgical instrument.
 4. The device according toclaim 3, wherein the channel is at least partially afforded along anelongate development of the hollow body.
 5. The device according toclaim 1, wherein the insertion portion is closed.
 6. The deviceaccording to claim 5, wherein the insertion portion is rounded.
 7. Thedevice according to claim 5, wherein the insertion portion is tapered.8. The device according to claim 1, wherein the longitudinal windowdevelops downstream of the insertion portion and terminates upstream ofa downstream end of the open portion.